Your session is about to expire
← Back to Search
NK1 Receptor Antagonist
Anti-Nausea Medication for Breast Cancer
Phase 3
Recruiting
Led By Luke Peppone
Research Sponsored by University of Rochester NCORP Research Base
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be scheduled to receive the same chemotherapy regimen as received at cycle 1
Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin. Herceptin (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 4
Awards & highlights
Study Summary
This trial will compare netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine to see if they are more effective in improving chemotherapy-induced nausea and vomiting in patients with breast cancer.
Who is the study for?
This trial is for women with breast cancer who haven't had chemotherapy before. They must be planning to receive certain chemo drugs and agree to use birth control if of child-bearing potential. Participants need an ECOG status of 0-2, a nausea score >=3 from previous treatment, and can read English. Exclusions include central nervous system disease, uncontrolled diabetes or heart issues, recent antipsychotic use, known drug allergies, severe liver or kidney problems.Check my eligibility
What is being tested?
The study compares the effectiveness of netupitant/palonosetron hydrochloride and dexamethasone combined with either prochlorperazine or olanzapine against a placebo in reducing nausea and vomiting caused by chemotherapy in breast cancer patients.See study design
What are the potential side effects?
Possible side effects may include headaches, constipation or diarrhea from anti-nausea meds; drowsiness or agitation from olanzapine; low blood pressure from prochlorperazine; and sleep disturbances or appetite changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will continue with the same chemotherapy treatment as my first cycle.
Select...
I am scheduled for a one-day chemo with doxorubicin, cyclophosphamide, or carboplatin.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average nausea defined as the average nausea rating across 15 assessment points (comparing prochlorperazine or olanzapine to control arm)
Secondary outcome measures
Average nausea defined as the average nausea rating across 15 assessment points (comparing olanzapine to prochlorperazine)
Presence of any vomiting (yes or no)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group III (net/pal hydro, dexa, olanzapine, placebo)Experimental Treatment6 Interventions
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Group II: Group II (net/pal hydro, dexa, prochlorperazine, placebo)Experimental Treatment6 Interventions
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Group III: Group I (netupitant/palonosetron hydrochloride, dexamethasoneExperimental Treatment5 Interventions
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Prochlorperazine
2015
Completed Phase 4
~550
Olanzapine
2005
Completed Phase 4
~5480
Find a Location
Who is running the clinical trial?
University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
7,492 Total Patients Enrolled
1 Trials studying Breast Cancer
1,432 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,924,305 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Luke PepponePrincipal Investigator - University of Rochester NCORP Research Base
University of Rochester NCORP Research Base
1 Previous Clinical Trials
108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have dementia.I can become pregnant and agree to use birth control during the study. I also had a negative pregnancy test recently.I have a history of brain-related health issues.I use benzodiazepines regularly or as needed for anxiety or breakthrough nausea.You are allergic to olanzapine or other drugs called phenothiazines.I am on warfarin and have my oncologist's approval to join this study.I have experienced significant nausea, scoring 3 or higher, during my first treatment cycle.I will continue with the same chemotherapy treatment as my first cycle.I am experiencing or at risk of a blocked intestine.I have severe liver or kidney problems, as diagnosed by my doctor.I am currently taking amifostine.I have breast cancer and haven't had chemotherapy, except methotrexate for a non-cancer condition.I am scheduled for a one-day chemo with doxorubicin, cyclophosphamide, or carboplatin.My anti-nausea treatment plan follows ASCO guidelines and does not include Akynzeo.I can take care of myself and am up and about more than half of my waking hours.I am over 80 and have my oncologist's approval to join this study.I have been treated with antipsychotic medication recently or plan to during the study.I have a heart condition like irregular heartbeat, uncontrolled heart failure, or recent heart attack.I am currently taking anticholinergic medications.I have not taken Akynzeo in the first treatment cycle.My diabetes or high blood sugar is not under control.I am currently taking quinolone antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (net/pal hydro, dexa, prochlorperazine, placebo)
- Group 2: Group III (net/pal hydro, dexa, olanzapine, placebo)
- Group 3: Group I (netupitant/palonosetron hydrochloride, dexamethasone
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators presently looking for participants in this trial?
"Active recruitment is ongoing for this clinical trial, which was first announced on April 19th, 2018. The latest update to the study's information was on May 17th, 2022. A total of 1200 patients are needed for the 18 different locations involved in the trial."
Answered by AI
What types of patients can benefit from Quality-of-Life Assessment?
"Quality-of-Life Assessment is commonly used to ameliorate ophthalmia, sympathetic. This treatment method can also improve other health concerns like communicable diseases, macular edema, and branch retinal vein occlusion."
Answered by AI
Do you know of other research teams who have looked into Quality-of-Life Assessment?
"The Quality-of-Life Assessment was first studied in 2002. As of right now, there have been a total of 20,128 completed studies with 602 active clinical trials. Many of these ongoing trials are taking place in Columbus, Ohio."
Answered by AI
Is Quality-of-Life Assessment a reliable method for gauging patient safety?
"There is already some evidence supporting the efficacy of Quality-of-Life Assessment, and it has received multiple rounds of data backing its safety; thus, we rate its safety as a 3."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger